Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years)

March 18, 2013 updated by: Forest Laboratories

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of Nebivolol in Younger Patients (18 - 54 Years) Who Have Stage 1 or 2 Essential Hypertension

The purpose of this study is to assess the efficacy, safety, and tolerability of 8 weeks of therapy with nebivolol in comparison to placebo in younger patients 18 - 54 years of age with stage 1 or stage 2 essential hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

641

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 065
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 067
      • Phoenix, Arizona, United States, 85014
        • Forest Investigative Site 070
    • California
      • Buena Park, California, United States, 90620
        • Forest Investigative Site 049
      • Burbank, California, United States, 91505
        • Forest Investigative Site 034
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 039
      • Fountain Valley, California, United States, 92708
        • Forest Investigative Site 024
      • Fresno, California, United States, 93726
        • Forest Investigative Site 020
      • Fresno, California, United States, 93726
        • Forest Investigative Site 021
      • Greenbrae, California, United States, 94904
        • Forest Investigative Site 040
      • La Mesa, California, United States, 91942
        • Forest Investigative Site 047
      • Los Angeles, California, United States, 90057
        • Forest Investigative Site 073
      • Roseville, California, United States, 95661
        • Forest Investigative Site 077
      • San Bernardino, California, United States, 92404
        • Forest Investigative Site 060
      • San Francisco, California, United States, 94115
        • Forest Investigative Site 054
      • Spring Valley, California, United States, 91978
        • Forest Investigative Site 018
    • Colorado
      • Denver, Colorado, United States, 80220
        • Forest Investigative Site 028
    • Florida
      • Brooksville, Florida, United States, 34601
        • Forest Investigative Site 059
      • Ft. Lauderdale, Florida, United States, 33306
        • Forest Investigative Site 033
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 006
      • Longwood, Florida, United States, 32779
        • Forest Investigative Site 044
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 001
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 012
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 032
      • Miami, Florida, United States, 33014
        • Forest Investigative Site 055
      • Oviedo, Florida, United States, 32765
        • Forest Investigative Site 045
      • St. Petersburg, Florida, United States, 33709
        • Forest Investigative Site 031
    • Georgia
      • Atlanta, Georgia, United States, 30084
        • Forest Investigative Site 009
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Forest Investigative Site 007
      • Morton, Illinois, United States, 61550
        • Forest Investigative Site 004
    • Indiana
      • Evansville, Indiana, United States, 47713
        • Forest Investigative Site 072
      • Newburgh, Indiana, United States, 47630
        • Forest Investigative Site 069
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Forest Investigative Site 025
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Forest Investigative Site 029
      • Madisonville, Kentucky, United States, 42431
        • Forest Investigative Site 068
    • Louisiana
      • Metairie, Louisiana, United States, 70005
        • Forest Investigative Site 061
      • New Orleans, Louisiana, United States, 70119
        • Forest Investigative Site 057
      • New Orleans, Louisiana, United States, 70119
        • Forest Investigative Site 058
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Forest Investigative Site 008
    • Massachusetts
      • Fall River, Massachusetts, United States, 02702
        • Forest Investigative Site 062
    • Michigan
      • Paw Paw, Michigan, United States, 49079
        • Forest Investigative Site 075
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Forest Investigative Site 019
      • Chaska, Minnesota, United States, 55318
        • Forest Investigative Site 017
    • Mississippi
      • Belzoni, Mississippi, United States, 39038
        • Forest Investigative Site 038
      • Olive Branch, Mississippi, United States, 38654
        • Forest Investigative Site 035
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 023
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 048
      • Las Vegas, Nevada, United States, 89101
        • Forest Investigative Site 052
    • New Jersey
      • Elizabeth, New Jersey, United States, 27609
        • Forest Investigative Site 014
      • Trenton, New Jersey, United States, 08611
        • Forest Investigative Site 051
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Forest Investigative Site 003
      • Charlotte, North Carolina, United States, 28277
        • Forest Investigative Site 010
      • Raleigh, North Carolina, United States, 27609
        • Forest Investigative Site 011
      • Raleigh, North Carolina, United States, 27609
        • Forest Investigative Site 016
      • Wilmington, North Carolina, United States, 28401
        • Forest Investigative Site 005
      • Winston-Salem, North Carolina, United States, 27103
        • Forest Investigative Site 036
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Forest Investigative Site 002
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Forest Investigative Site 050
    • Oregon
      • Portland, Oregon, United States, 33709
        • Forest Investigative Site 030
    • Pennsylvania
      • Downingtown, Pennsylvania, United States, 19335
        • Forest Investigative Site 056
    • South Carolina
      • Pelzer, South Carolina, United States, 29669
        • Forest Investigative Site 022
    • Texas
      • Beaumont, Texas, United States, 77701
        • Forest Investigative Site 053
      • Boerne, Texas, United States, 78006
        • Forest Investigative Site 066
      • Corpus Christi, Texas, United States, 78404
        • Forest Investigative Site 076
      • Dallas, Texas, United States, 75234
        • Forest Investigative Site 037
      • Haltom City, Texas, United States, 84070
        • Forest Investigative Site 043
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 026
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 027
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 015
      • Houston, Texas, United States, 77081
        • Forest Investigative Site 074
    • Utah
      • Orem, Utah, United States, 84058
        • Forest Investigative Site 071
      • Sandy, Utah, United States, 84070
        • Forest Investigative Site 042
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site 063
      • Norfolk, Virginia, United States, 23502
        • Forest Investigative Site 064
    • Washington
      • Port Orchard, Washington, United States, 98366
        • Forest Investigative Site 046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female outpatients, of age 18 - 54 years
  • Patients diagnosed with stage 1 or stage 2 essential hypertension
  • Normal physical examination findings and electrocardiogram (ECG) results or abnormal findings judged by the Investigator to be not clinically significant

Exclusion Criteria:

  • Secondary hypertension or severe hypertension
  • History of Type 1 diabetes mellitus
  • A medical contraindication to discontinuing a current antihypertensive therapy
  • Clinically significant respiratory disease that prohibit use of a beta blocker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Drug: Nebivolol
Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
Placebo Comparator: 2
Dose-matched placebo
Drug: Placebo
Dose-match placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated Diastolic Blood Pressure (DBP)
Time Frame: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Diastolic Blood Pressure (DBP) at Week 8 as measured by an Omron device. The primary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough Seated Systolic Blood Pressure (SBP)
Time Frame: Change from Baseline to Week 8
Change from baseline in mean seated trough cuff Systolic Blood Pressure (SBP) at Week 8 as measured by an Omron device. The secondary efficacy analysis was based on the Intent to Treat (ITT) population using a Last Observation Carried Forward (LOCF) approach.
Change from Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forest Laboratories

Investigators

  • Study Director: Tatjana Lukic, MD, M. Sc., Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

August 10, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (Estimate)

August 12, 2011

Study Record Updates

Last Update Posted (Estimate)

May 16, 2013

Last Update Submitted That Met QC Criteria

March 18, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEB-MD-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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